Yesterday, the Federal Circuit provided much-anticipated guidance on the scope of the America Invents Act’s “on-sale” bar provision. Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., et al., Nos. 2016-1284, 2016-1787...more
5/3/2017
/ Abbreviated New Drug Application (ANDA) ,
America Invents Act ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
On-Sale Bar ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Prescription Drugs ,
Teva Pharmaceuticals
In a highly-anticipated ruling, the Supreme Court held that patent holders can recover damages for infringement even when the patent holders unreasonably delayed filing a lawsuit. In SCA Hygiene Products AB v. First Quality...more
3/23/2017
/ Damages ,
Equitable Relief ,
Intellectual Property Protection ,
Laches ,
Patent Act ,
Patent Infringement ,
Patent Litigation ,
Patents ,
SCA Hygiene Products Aktiebolag v First Quality Baby Products ,
SCOTUS ,
Statute of Limitations
The Federal Circuit’s recent decision in Amgen Inc. v. Apotex Inc., No. 16-1308, provides new guidance on the timeline of biosimilar approval and the impact to commercial marketing.
The ruling weighed in on a key...more
7/11/2016
/ Amgen ,
Apotex ,
Biosimilars ,
BPCIA ,
Generic Drugs ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Preliminary Injunctions
Earlier this month the Food and Drug Administration ("FDA") published three industry guidances for the Biologics Price Competition and Innovation Act of 2009 ("BPCIA")....more
On April 13, 2015, the Inspector General (IG) of the Department of Health and Human Services announced in a letter to Senator Bernard Sanders (I. VT), that it would investigate recent price hikes for generic drugs. Generic...more
Tuesday the Supreme Court, in B&B Hardware Inc. v. Hargis Industries Inc. et al., case number 13-352, decided that Trademark Trial and Appeal Board ("TTAB") decisions preclude federal courts from ruling on issues that are...more
In This Issue:
- I. Traditional Use of General Jurisdiction in Hatch-Waxman Cases
- II. Amenability to General Jurisdiction May Be Waning
- III. Freedom from Jurisdiction Could Be An Advantage
-...more